Health Canada

Health Canada

January 16, 2010 09:22 ET

Information Update: Rolaids Antacid Tablets Packaged in Bottles Recalled Due to Possible Health Risks

OTTAWA, ONTARIO--(Marketwire - Jan. 16, 2010) - Health Canada is informing Canadians that Rolaids antacid tablets packaged in bottles of 150 and 100 counts are being voluntarily recalled in Canada by the distributor, McNeil Consumer Healthcare (Canada), Division of Johnson & Johnson Inc. The recall comes in light of reports in the U.S. of an unusual mouldy, musty, or mildew-like odour that was, in some cases, associated with nausea, stomach pain, vomiting and diarrhea.

The distributor has confirmed that the recall does not extend beyond the Rolaids antacid tablets packaged in bottles of 150 and 100 counts. The recalled products are:



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Description DIN/NPN UPC (EA) LOT Numbers
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ROLAIDS® Regular NPN 02239904 060093200206 AAA526, ACA014,
Strength Original 150s ADA269, AFA052
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ROLAIDS® Regular NPN 02239904 060093200213 ABA151, ABA400,
Strength Spearmint ABA401, ABA402,
150s AEA013, ALA257
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ROLAIDS® Extra NPN 02240505 060093200237 SSA156, ABA398,
Strength Freshmint SSA236, ADA181,
100s AHA044, AEA198
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ROLAIDS® Extra NPN 02240505 060093200244 AAA249, ACA259,
Strength Mixed Fruit AEA196, AFA318,
100s ALA133
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ROLAIDS® Multi- DIN 02247314 060245200443 ABA535, AHA075
Symptom Berry 100s
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Rolaids antacids are widely used to relieve acid indigestion and heartburn. Based on an ongoing investigation by the U.S. manufacturer, McNeil Consumer Healthcare, the unusual smell has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials used in the affected product.

The health effects of this chemical have not been well studied. According to the U.S. manufacturer, all of the reactions (e.g. nausea, stomach pain, diarrhea, etc.) reported in the U.S. to date have been temporary and non-serious.

Consumers who have purchased any of the above-listed products and who have concerns about their health should speak to a health care professional. The distributor advises consumers who have purchased bottles of Rolaids antacid tablets to stop using the product and to contact McNeil Consumer Healthcare (Canada) at 1-800-661-4659, Monday-Friday 8a.m. to 8p.m. EST for instructions on how to return or replace the product. Consumers can also visit www.jnjcanada.com (http://www.jnjcanada.com/).

The recall is part of an expansion of an earlier U.S. recall by the manufacturer of certain Tylenol Arthritis products following reports of the same smell and stomach problems. This earlier recall did not affect products sold in Canada. Information on the earlier recall of products in the U.S. can be found in the following Health Canada Foreign Product Alert (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-213-eng.php). Information on the expanded recall of products sold in the U.S. is available on the U.S. Food and Drug Administration website (http://www.fda.gov/Safety/Recalls/ucm197746.htm).

Consumers requiring more information about this information update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

- Report online (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect™ Canada (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) section of the Health Canada website

- Call toll-free at 1-866-234-2345

- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and either:

-- Fax toll-free to 1-866-678-6789

-- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect™ Canada (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) section of the Health Canada website. The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this section.

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709